Core Insights - SeaStar Medical Holding Corporation announced the publication of early post-approval clinical experience of the QUELIMMUNE therapy in Pediatric Nephrology, demonstrating strong survival data and a favorable safety profile [2][3][4] Group 1: Clinical Data and Outcomes - The QUELIMMUNE therapy showed a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90 among the first 21 pediatric patients with Acute Kidney Injury (AKI) and sepsis [4] - The therapy is associated with a 50% reduction in patient mortality at 60 days compared to historical data, consistent with results from prior clinical trials [4][10] - Among patients treated with QUELIMMUNE and extracorporeal membrane oxygenation (ECMO), a 60% survival rate was observed at Day 90 [5] Group 2: Safety Profile - No device-related adverse events or infections were reported in the initial patient cohort, indicating a favorable safety profile for the QUELIMMUNE therapy [4][6] - The absence of immunosuppressive effects further supports the therapy's safety in critically ill pediatric patients [4] Group 3: Regulatory and Research Framework - The SAVE Registry, a post-approval surveillance registry, is designed to collect additional safety and clinical effectiveness data for QUELIMMUNE therapy, initially requiring the enrollment of 300 patients, later reduced to 50 after discussions with the FDA [6][9] - The QUELIMMUNE therapy was approved under a Humanitarian Device Exemption, necessitating participation in the SAVE Registry for real-world data collection [9][14] Group 4: Broader Implications and Adoption - The QUELIMMUNE therapy has been adopted by several nationally recognized children's medical centers in the U.S., indicating growing acceptance and potential for broader application [7] - The therapy aims to address the urgent need for effective treatments for critically ill pediatric patients facing life-threatening conditions due to AKI and sepsis [13][14]

Core Insights - SeaStar Medical Holding Corporation announced positive early post-approval clinical experience for QUELIMMUNE therapy, showing strong survival rates in pediatric patients with Acute Kidney Injury (AKI) and sepsis [1][2][3] Group 1: Clinical Data and Outcomes - The SAVE Registry reported a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90 for pediatric patients treated with QUELIMMUNE therapy [3] - No device-related adverse events or infections were observed in the first 21 patients, indicating a favorable safety profile [3][5] - Among patients treated with QUELIMMUNE and requiring extracorporeal membrane oxygenation (ECMO), a 60% survival rate was noted at Day 90 [4] Group 2: Regulatory and Adoption Insights - The FDA initially required 300 patients for the SAVE Registry but reduced the target to 50 after reviewing data from the first 21 patients [5] - QUELIMMUNE therapy has been adopted by several top-rated children's medical centers across the United States [6] Group 3: Company Background and Product Information - SeaStar Medical focuses on transforming treatments for critically ill patients facing organ failure, with QUELIMMUNE being its first commercial product approved in 2024 [12][13] - The Selective Cytopheretic Device (SCD) therapy aims to neutralize overactive immune cells and mitigate destructive hyperinflammation, with potential applications in various acute and chronic conditions [11]

Core Insights - SeaStar Medical Holding Corporation announced positive preliminary results from the SAVE Surveillance Registry, highlighting the effectiveness of QUELIMMUNE therapy for critically ill pediatric patients with Acute Kidney Injury (AKI) and sepsis [1][2] Group 1: Clinical Results - The first 21 pediatric patients treated with QUELIMMUNE therapy showed zero device-related adverse events or infections, with a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90 [2][3] - Among patients treated with QUELIMMUNE and requiring extracorporeal membrane oxygenation (ECMO), a 60% survival rate was observed at Day 90 [3] - For pediatric survivors without a history of end-stage renal disease (ESRD) or recent kidney transplant, 75% were dialysis-free at Day 28, and 82% at Day 90 [3] Group 2: Therapy Overview - QUELIMMUNE therapy is designed for children with AKI and sepsis, weighing 10 kilograms or more, and is administered in conjunction with Renal Replacement Therapy (RRT) [8] - The Selective Cytopheretic Device (SCD) therapy aims to neutralize overactive immune cells and mitigate destructive hyperinflammation, which can lead to organ failure [11] - QUELIMMUNE therapy was approved under a Humanitarian Device Exemption in February 2024, requiring participation in the SAVE Surveillance Registry for data collection [8] Group 3: Future Implications - The SAVE Surveillance Registry aims to confirm the safety and efficacy of QUELIMMUNE therapy, with plans to collect data from up to 300 patients [4] - Initial results from the registry are expected to support broader adoption of QUELIMMUNE therapy and inform payer discussions [4] - SeaStar Medical is also conducting a pivotal clinical trial (NEUTRALIZE-AKI) for adult patients with AKI requiring continuous renal replacement therapy [12]